Lefabac 600 | 1 PC Tablet

✔️ Dosage & Administration of Lefamulin

Adult Patients with CABP

Injection (IV): 150 mg every 12 hours as an intravenous infusion over 60 minutes for 5–7 days.

May switch to oral tablets during the course.

Tablet (Oral): 600 mg every 12 hours for 5 days.

Hepatic Impairment Adjustments

Severe Impairment (Child-Pugh C):

IV: Reduce dose to 150 mg IV over 60 minutes once every 24 hours.

Oral: Not recommended (insufficient clinical data).

Mild to Moderate Impairment (Child-Pugh A or B):

IV: No dose adjustment required.

Oral: No adjustment needed for mild cases; not recommended for moderate.

Administration Instructions

Injection (IV):

Dilute the 15 ml vial in 250 ml citrate-buffered 0.9% sodium chloride provided with the pack.

Infuse over 60 minutes.

Do not mix with other additives or use series connections.

Tablet (Oral):

Take at least 1 hour before or 2 hours after meals.

Do not crush or divide tablets.

Missed Dose

• Take the missed dose as soon as possible, if more than 8 hours remain before the next scheduled dose.
• If less than 8 hours remain, skip the missed dose and continue with the next scheduled dose.
• Do not double up doses.

✔️ Drug Interactions

Avoid with: Strong/moderate CYP3A4 or P-glycoprotein inducers, as they lower drug levels.

QT-prolonging drugs: Risk of additive QT interval prolongation.

Grapefruit: Avoid due to CYP3A inhibition, which may increase serum concentration.

✔️ Side Effects

• Cardiac: QT interval prolongation, arrhythmias.
• GI: Nausea, diarrhea, vomiting, abdominal pain.
• Infectious: Clostridioides difficile-associated diarrhea (CDAD).

✔️ Contraindications

• Known hypersensitivity to Lefamulin or pleuromutilin-class drugs.
• Use with CYP3A4 substrates that prolong QT interval.
• Not recommended in pregnant women or patients under 18 years.

✔️ Use in Pregnancy & Lactation

• Pregnancy: Animal studies show increased risk of stillbirth and malformations. Use only if potential benefits outweigh risks.
• Lactation: Unknown if excreted in human milk; animal studies show presence in milk. Breastfeeding should be avoided during treatment and for 2 days after the last dose.

✔️ Precautions & Warnings

• Risk of CDAD ranging from mild diarrhea to fatal colitis.
• Avoid in patients with:
• Pre-existing QT prolongation.
• Ventricular arrhythmias (e.g., torsades de pointes).
• Use of Class IA/III antiarrhythmics or other QT-prolonging agents (antipsychotics, erythromycin, moxifloxacin, tricyclic antidepressants).

✔️ Storage:

Store below 30°C, in a dry place, protected from light. Do not refrigerate or freeze.